NiteTime Cough DayTime Cough

Product NDC
41250-031
Requested package NDC
41250-031-02
11-digit product format
412500031
Labeler code
41250
Product ID
41250-031_bb474676-2e42-41b8-8e50-d3a1f2cd821a
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, doxylamine succinate
Dosage form
KIT
Labeler
Meijer Distribution Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-02-13
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41250-03141250-031-02DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-031-02412500031021 KIT in 1 KIT (41250-031-02) * 355 mL in 1 BOTTLE (41250-668-40) * 355 mL in 1 BOTTLE (41250-473-40) 1 kit2013-02-130000-00-00NoNoCurrent